Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia (BEST-CLI)

Carelon Research

Status: Completed

Conditions: Critical Limb Ischemia

Treatments: Device: Endovascular revascularization; Procedure: Open surgical revascularization

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT02060630

BEST-CLI Trial

1U01HL107407 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will compare the effectiveness of best available surgical treatment with best available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible for both treatment options.

Full description

Male and female subjects aged 18 years or older will be randomized to receive either open surgical treatment or endovascular treatment. They will be followed for at least 2 years and up to 4 years and 2 months after treatment to primarily assess survival and major adverse limb events in the index or treated limb, and secondarily, to determine clinical and cost effectiveness outcomes after treatment. These outcomes (survival-free of major limb events and clinical, functional and cost effectiveness) will be compared within two cohorts of subjects: those with an available single-segment great saphenous vein, and those with an alternative conduit. The null hypotheses for both cohorts is that there will be no difference in MALE-free survival between best endovascular therapy and best surgical therapy.

Enrollment: 1,843 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, age 18 years or older.
2. Infrainguinal PAOD (occlusive disease of the arteries below the inguinal ligament).
3. CLI, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford categories 4-6.
4. Candidate for both endovascular and open infrainguinal revascularization as judged by the treating investigators
5. Adequate aortoiliac inflow.
6. Adequate popliteal, tibial or pedal revascularization target defined as an infrainguinal arterial segment distal to the area of stenosis/occlusion which can support a distal anastomosis of a surgical bypass.
7. Willingness to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.

Exclusion criteria

1. Presence of a popliteal aneurysm (>2 cm) in the index limb.

2. Life expectancy of less than 2 years due to reasons other than PAOD.

3. Excessive risk for surgical bypass (as determined by the operating surgeon and the CLI Team)

4. Planned above ankle amputation on ipsilateral limb within 4 weeks of index procedure.

5. Active vasculitis, Buerger's disease, or acute limb-threatening ischemia

6. Any prior index limb infrainguinal stenting or stent grafting associated with significant restenosis within 1 cm of stent or stent-graft, unless the occlusion/restenosis site is outside the intended treatment zone (i.e.,. a tibial vessel that is not currently intended to be revascularized as a part of the treatment for CLI).

7. Any of the following procedures performed on the index limb within 3 months prior to enrollment:

   1. Infrainguinal balloon angioplasty, atherectomy, stent, or stentgraft;
   2. Infrainguinal bypass with either venous or prosthetic conduit

8. Open surgical inflow procedure (aortofemoral, axillofemoral, iliofemoral, thoracofemoral or femorofemoral bypass) within 6 weeks prior to enrollment

9. Current chemotherapy or radiation therapy.

10. Absolute contraindication to iodinated contrast due to prior near-fatal anaphylactoid reaction (laryngospasm, bronchospasm, cardiorespiratory collapse, or equivalent) which would preclude patient participation in angiographic procedures.

11. Pregnancy or lactation.

12. Administration of an investigational drug for PAD within 30 days of randomization.

13. Participation in a clinical trial (except observational studies) within the previous 30 days.

14. Prior enrollment or randomization into BEST-CLI.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,843 participants in 4 patient groups

Available vein, open surg. revasc.

Other group

Description:

Subjects with an available SSGSV cohort randomized to open surgical revascularization

Treatment:

Procedure: Open surgical revascularization

Available vein, endovasc. revasc.

Other group

Description:

Subjects with an available SSGSV cohort randomized to endovascular revascularization

Treatment:

Device: Endovascular revascularization

Alternative conduit, open surg. revasc.

Other group

Description:

Subjects with an alternative conduit cohort randomized to open surgical revascularization

Treatment:

Procedure: Open surgical revascularization

Alternative conduit, endovasc. revasc.

Other group

Description:

Subjects with an alternative conduit cohort randomized to endovascular revascularization

Treatment:

Device: Endovascular revascularization